Defective Vaginal Mesh Hit the Market Three Years Before FDA Clearance

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common health problems in women, which can be surgically corrected. Transvaginal mesh is sometimes used in these surgeries. The Gynecare Prolift mesh, made by Johnson & Johnson, was on the market three years before receiving clearance by U.S. regulators. If you have been injured by defective vaginal mesh, our Louisiana defective drug attorneys can help you get the compensation you deserve.

Fast-Track 510(k) Clearance

The Prolift went on the market without approval by the U.S. Food and Drug Administration (FDA). When the FDA discovered this, two years later, it did not sanction J&J, but required the company to submit a 510(k) application for the Prolift.

510(k) clearance is used for new medical devices that are deemed similar to approved medical devices. It is a faster way to get clearance that does not require the device to go through the normal approval process including clinical trials.

About 28 devices are cleared each year based on existing devices that are defective. Those new devices are five times more likely to be recalled for safety problems.

Vaginal Mesh Complications

Although the Prolift was eventually cleared by the FDA, it is still causing injuries. In fact, one study using the Prolift was cut short because of the high rate of erosion, a complication which requires additional surgery to remove the mesh and can cause permanent injuries and fatal infections.

If you are a resident of Louisiana and have been harmed by defective vaginal mesh or lost a loved one to this dangerous medical device, please contact our Louisiana defective drug attorneys at 1-877-LOSS-RECOVER (567-7732). Our qualified and successful product liability lawyers will get you the money you deserve, so call our law firm today.

Pradaxa Heart Attack and Bleeding Claims in Louisiana

Does your doctor have you on a blood thinner to prevent stroke? If so, you may be in grave danger. The anticlotting drug Pradaxa (dabigatran) is currently under review by the U.S. Food and Drug Administration (FDA) based on concerns that it may be more likely than previously believed to cause fatal bleeding events. It has also been linked to an increased risk of heart attack.

Pradaxa vs. Other Blood Thinners

Blood thinners are often prescribed to prevent the formation of blood clots that can lead to stroke. All blood thinners carry the risk of causing uncontrolled bleeding, even fatal internal bleeding.

The problem with Pradaxa is that there is no antidote, or reversal agent, and the normal techniques used to stop the bleeding with other blood thinners do not work in people taking this new drug.

Since Pradaxa cannot be neutralized, the only way to get the blood clotting again, and stop the bleeding, is to get the drug out of a person’s system. Dialysis is used to remove as much as possible, but it can only remove up to 60% of the drug, and it takes at least two to three hours to accomplish this. Patients with serious bleeding can easily die before the dialysis is complete.

If you are a resident of Louisiana and have been harmed by Pradaxa or lost a loved one to this deadly drug, please contact our Louisiana defective drug attorneys at 1-877-LOSS-RECOVER (567-7732). Our qualified and successful product liability lawyers will get you the money you deserve, so call our law firm today.

Is Actos Safer Than Avandia?

Actos (pioglitazone) and Avandia (rosiglitazone) are similar medications prescribed to treat patients with Type 2 diabetes. Actos gained popularity when Avandia fell under public scrutiny for being linked to heart complications. However, a recent study revealed that Actos increases the risk of heart attack and death just as much as Avandia.

If you have taken either Avandia or Actos and suffered heart problems, these defective drugs may be the cause. Contact a Louisiana Actos/Avandia injury attorney to begin the claims process and collect the damages you deserve.

The Risks Are the Same for Both Drugs

The study, which lasted just under three years, observed participants as they took the two drugs for 14 months. Throughout that time, four percent of Actos users and four percent of Avandia users suffered heart attacks, heart failure, or died.

Of the 602 participants Avandia users:

  • 96 had a heart attack
  • 265 experienced heart failure
  • 24 suffered both heart attack and heart failure
  • 217 died

Of the 599 participants who took Actos:

  • 121 had a heart attack
  • 243 experienced heart failure
  • 18 suffered both a heart attack and heart failure
  • 217 died

If you have been injured or lost a loved one because of Actos or Avandia, please contact or call our Louisiana Actos/Avandia injury attorneys at 1-877-LOSS-RECOVER (567-7732) to the money you and your family deserve.